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Test strip for combined detection of CRP and SAA, kit and preparation method

A technology of combined detection and test strips, which is applied in the field of kits and preparations, combined detection of CRP and SAA test strips, can solve problems such as narrow linearity, and achieve the effects of expanding the degree of discrimination, making it simple, and broadening the linearity

Pending Publication Date: 2022-01-14
上海艾瑞德生物科技有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0005] However, the lateral flow chromatography products currently on the market for simultaneous quantitative detection of CRP / SAA all have the disadvantage of narrow linearity, so the linearity needs to be widened to meet actual clinical needs

Method used

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  • Test strip for combined detection of CRP and SAA, kit and preparation method
  • Test strip for combined detection of CRP and SAA, kit and preparation method
  • Test strip for combined detection of CRP and SAA, kit and preparation method

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0057] The present embodiment provides a kind of test strip of joint detection CRP and SAA, the test strip assembled by this method refers to figure 1 shown.

[0058] The detection test strip includes a PVC bottom plate 2, on which a nitrocellulose membrane 6 (NC membrane) is arranged, one end of the nitrocellulose membrane is connected with a second layer of sample pad 9, and the other end of the sample pad is connected with a fluorescent particle binding pad 8 , the other end of the fluorescent particle binding pad is connected with the first layer of sample pad 7 . The other end of the nitrocellulose membrane is connected with an absorbent pad 1 . A CRP detection line 5 coated with CRP monoclonal antibody 2, a SAA detection line 4 coated with SAA monoclonal antibody 2, and a goat anti-rabbit IgG polyclonal antibody coated in parallel are arranged on the nitrocellulose membrane 6 Quality control line 3.

[0059] The CRP antibody 1 conjugates of 150nm±25nm and 330nm±25nm, ...

experiment example 1

[0083] Preparation of Calibration Curve.

[0084] The test strip prepared by the above method was used for the determination of the calibrator, and each concentration was repeated 5 times. Use the I-Reader S automatic dry immunoassay analyzer of Shanghai Ai Ruide Biotechnology Co., Ltd. to test, and the result can be obtained in 3 minutes. The standard curve data is shown in Table 1 and Table 2, and the standard curve is shown in Table 1. figure 2 and image 3 shown.

[0085] From Table 1, Table 2 and figure 2 , image 3 As shown, the precision and sensitivity of each concentration point of the CRP and SAA standard curves are good, and there is a significant distinction between CRP at a concentration of 0.4 mg / L and a value of 0, and that of SAA at a concentration of 0.5 mg / L and a value of 0. Good linearity.

[0086] Table 1 CRP quantitative detection calibration curve data

[0087] CRP concentrationmg / L 300 200 160 100 50 20 10 repeat 1 3179 2...

experiment example 2

[0091] In this experiment example, the test experiment of the sample is carried out.

[0092] Carry out sample (donated by Changzhou Sinopharm Medical Testing Laboratory Co., Ltd.) test based on the calibration curve of Experimental Example 1, and test the target value with the Siemens system and its supporting CRP and SAA kits, and perform correlation analysis, such as Figure 4 and Figure 5 As shown, the CRP correlation coefficient R 2 is 0.9868, SAA correlation coefficient R 2 It is 0.9854, and the correlation between the two is good.

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Abstract

The invention discloses a test strip for combined detection of CRP and SAA, a kit and a preparation method, and relates to the technical field of in-vitro diagnostic reagents. The test strip can broaden the upper and lower limits of CRP and SAA combined detection, can detect low-concentration and high-concentration samples at the same time, and can meet the actual clinical requirements. In addition, the test strip has relatively high CRP and SAA detection sensitivity, and is high in precision and short in detection time. When the antigen concentration is low, fluorescent microspheres with the particle size of 330 + / -25 nm play a main role, and the low-concentration antigen can be stably detected. When the concentration of the antigen is high, fluorescent microspheres with the particle size of 150nm + / -25nm play a main role, so that the antigen in a to-be-detected sample can be detected on the premise of not dilution again, the discrimination of a high-concentration region is expanded, and the linearity is widened.

Description

technical field [0001] The invention relates to the technical field of in vitro diagnostic reagents, in particular to a test strip, a kit and a preparation method for joint detection of CRP and SAA. Background technique [0002] C-reactive protein (C-reaction, CRP) is an acute phase protein synthesized by the liver. Existing studies have shown that in cases of inflammatory diseases, rheumatic fever, burns, rheumatoid arthritis, local abscesses, peritonitis, myocardial infarction, etc., the increase of CRP levels has been detected, and as the condition improves, CRP gradually returns to normal Level. [0003] SAA1 and SAA2 in the serum amyloid A (Serum amyloid A protein, SAA) protein family are also a protein produced in the acute phase response. Elevated levels of SAA in serum can be observed in various clinical manifestations, such as inflammatory diseases, atherosclerosis, coronary heart disease, acute transplant rejection, tumors, etc. Similar to CRP, detecting the con...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): G01N33/68G01N33/558G01N33/577G01N33/58G01N33/543G01N33/531
CPCG01N33/6893G01N33/558G01N33/577G01N33/582G01N33/54313G01N33/531G01N2333/4737G01N2800/7095
Inventor 张颖王茜范金坤马亚飞
Owner 上海艾瑞德生物科技有限公司
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